Paris (AFP)

A late "incomprehensible" withdrawal from the Mediator, whose adverse effects were reported at least ten years before its effective suspension of the market: three Igas officials on Tuesday overwhelmed the Servier laboratories and the Agence du médicament, tried in Paris in Paris. the affair of this sanitary scandal.

On January 15, 2011, Aquilino Morelle, former intern of Paris hospitals, Etienne Marie, a senior official at the Ministry of Health, and Anne-Carole Bensadon, general practitioner, delivered at a press conference the conclusions of their vitriolic investigation. on the Mediator and Servier laboratories, accused of having "anesthetized" the actors in the drug chain.

Nearly nine years later, at the helm of the Criminal Court, the words differ but the finding of the former mission of the General Inspectorate of Social Affairs (Igas) is the same: the Mediator "should have been withdrawn in 1999 ", ten years before its effective suspension from the market, and not having done so is" incomprehensible ".

1999, pivotal year, insists Dr. Bensadon, is that of "strong alerts", "capitals" on the adverse effects of the drug: a first case of valvulopathy, aortic insufficiency with a "plausible imputability" to the Mediator is reported in February, followed by a case of pulmonary arterial hypertension (PAH), a very rare disease, in June.

- "Doubt benefits the drug" -

Despite these "extremely worrying signals", the drug is not suspended by the health authorities, complains Anne-Carole Bensadon, which mentions two other "missed opportunities", in 2005 and 2007, while the drug has just been removed by Servier in Spain and Italy and that cases of diseases are increasing in France.

Noting the bankruptcy of a system of pharmacovigilance in which "doubt benefits the drug", Dr. Bensadon bitterly observes that "in this tragic story, the life of the drug is a priority in the life of the patient."

"Never the benefit-risk (the Mediator, Ed) has been studied properly", storm in turn Aquilino Morelle, the old pen of François Hollande at the Elysee, which dwelled for a long time on the pharmacological properties of this medicine.

Servier laboratories are alleged to have knowingly concealed the Mediator's anorectic properties and side effects, and thus to have misled the Medicines Agency, which they dispute.

Held responsible for hundreds of deaths, this adjuvant to the treatment of diabetes had been widely prescribed as appetite suppressant "because it was an anorectic," says Mr Morelle, citing the own work of Servier laboratories.

If it had been envisaged in 1974 (date of the marketing authorization, ed) as the amphetamine derivative that it is, then very probably it would never have been authorized ", assures Mr. Morelle, right at the helm next to his former colleagues.

And this medical doctor to assert: in this case, "the salvation came from outside, whistleblowers" as the Brest Irène pulmonologist Frachon or the medical journal Prescrire, "outside the system", repeats- there.

Subjected to a fire fueled by questions of defense Servier laboratories who believe that the Igas report was "biased" and feed the judicial information opened a month later, the witnesses may have appeared on the defensive, but not have not varied in their explanations.

Their hearing was suspended around 8:00 pm and will resume Wednesday afternoon.

They are the first to be heard by the court since the opening on September 23 of this river trial, scheduled to end in late April 2020.

Eleven legal entities and twelve individuals appear in total. The National Agency for Drug Safety (ANSM, former Afssaps) is judged alongside Servier laboratories for "homicide and unintentional injuries" by "negligence" for delaying the suspension of the sale of the drug.

"The ANSM will not seek the release in this case," said Tuesday its Director General Dominique Martin, who represents the Agency at trial. "I consider that the decision to withdraw the drug in 2009 was late, too late, and should have been taken sooner," he said, referring to "a human tragedy and a health disaster."

© 2019 AFP